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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEVA PHARMACEUTICAL PARAGARD PARAGARD 380A

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TEVA PHARMACEUTICAL PARAGARD PARAGARD 380A Back to Search Results
Device Problem Component Missing (2306)
Patient Problems Menstrual Irregularities (1959); Abdominal Cramps (2543); Intermenstrual Bleeding (2665)
Event Date 06/25/2013
Event Type  Injury  
Event Description

Patient presented to office with (b)(4) paragard iud in situ requesting to have iud removed as she had become pregnant and wishes to terminate pregnancy. Iud removed with moderate amount traction and found to have missing cross arm, patient had small amount of bleeding then stopped quickly.

 
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Brand NamePARAGARD
Type of DevicePARAGARD 380A
Manufacturer (Section D)
TEVA PHARMACEUTICAL
MDR Report Key3243367
MDR Text Key3687081
Report Number3243367
Device Sequence Number1
Product Code HDT
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 07/03/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date06/25/2013
Device Age8 yr
Event Location Outpatient DIAGNOSTIC Facility
Date Report TO Manufacturer07/02/2013
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 07/08/2013 Patient Sequence Number: 1
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